Agency Response Letter GRAS Notice No. GRN 000261 - Additional Correspondence
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See also Generally Recognized as Safe (GRAS).
CFSAN/Office of Food Additive Safety
October 14, 2016
Gary L. Yingling
Morgan, Lewis & Bockius LLP
1111 Pennsylvania Avenue, NW
Washington, DC 20004
Re: GRAS Notice No. GRN 000261
Dear Mr. Yingling:
The Food and Drug Administration (FDA) is responding to the supplement, dated January 19, 2016, that you sent, on behalf of Grain Millers, Inc. (Grain Millers) regarding additional uses for the subject of GRN 000261. You initially submitted GRN 000261, on behalf of Grain Millers in accordance with the agency’s proposed regulation, proposed 21 CFR 170.36 (62 FR 18938; April 17, 1997; Substances Generally Recognized as Safe (GRAS); the GRAS proposal). Additional clarifying information regarding the supplement was received on April 7, 2016, and September 21, 2016.
GRN 000261 informed FDA of the view of Grain Millers that oat hull fiber is GRAS, through scientific procedures, for use as (1) an ingredient in bread/pizza crust, cookies/crackers/bars, cereal (hot and cold), baby food cereal, and snacks (fried and baked) at levels ranging from 5 percent to 14 percent by weight; (2) as an ingredient in breaders and batters applied in coating onto meat and poultry at levels ranging from 2 percent by weight of the total food system (breaded or coated meats) to 5 percent by weight of the dry coating system (breader and batter); and 3) as an extender in meat products at levels ranging from 3 percent to 5 percent. In a letter dated February 3, 2009, FDA informed Grain Millers that the agency had no questions at that time regarding Grain Millers’ conclusion that oat hull fiber is GRAS under the intended conditions of use.
In the supplement dated January 19, 2016, Grain Millers informs FDA of its view that oat hull fiber is GRAS, through scientific procedures, for use as an anti-caking agent within powdered or crystallized organic acids and/or oleoresin-containing injectable brines for meat and poultry at levels below 2 percent (w/w) of the dry mixtures and no more than 0.1% of the total formulation. Grain Millers states that the identity, method of manufacture, and estimates of dietary exposure are the same as discussed in GRN 000261. Grain Millers considers that there is no evidence that this use as an anti-caking agent presents a new question of safety to the consumer.
Use in Products under USDA Jurisdiction
During its evaluation of the supplement to GRN 000261, FDA consulted with the Risk, Innovations, and Management Staff (RIMS) of the Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture (USDA). Under the Federal Meat Inspection Act, Poultry Products Inspection Act, and the Egg Products Inspection Act, FSIS is responsible for determining the efficacy and suitability of food ingredients in meat, poultry, and egg products as well as prescribing safe conditions of use. Suitability relates to the effectiveness of the ingredient in performing the intended purpose of use and the assurance that the conditions of use will not result in an adulterated product, or one that misleads consumers.
FSIS informed FDA that it has no objection to the use of oat hull fiber for use as an anti-caking agent within powdered or crystallized organic acids and/or oleoresin-containing injectable brines for meat and poultry at levels below 2 percent (w/w) of the dry mixtures and no more than 0.1% of the total formulation.
FSIS stated that regarding labeling, oat hull fiber is required to be listed as “oat hull fiber” or as “isolated oat product” (if under 85 percent dietary fiber) in the ingredients statement. FSIS advises that if Grain Millers has any questions regarding labeling, they should be directed to Ms. Rosalyn Murphy-Jenkins at (301) 504-0879 or via email at Rosalyn.Murphy-Jenkins@fsis.usda.gov. FSIS further advises that if Grain Millers has any additional regulatory questions they be directed to Dr. William Shaw Jr., Director, Risk, Innovations, and Management Staff, Office of Policy and Program Development, Food Safety and Inspection Service, Stop Code 3782, Patriots Plaza III, 8-163A, 1400 Independence Avenue, SW, Washington, DC 20250-3700.
Section 301(ll) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
Section 301(ll) of the FD&C Act prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FD&C Act, a biological product licensed under section 351 of the Public Health Service Act, or a drug or a biological product for which substantial clinical investigations have been instituted and their existence made public, unless one of the exemptions in section 301(ll)(1)-(4) applies. In its review of Grain Millers’ supplement that oat hull fiber is GRAS for the intended use, FDA did not consider whether section 301(ll) or any of its exemptions apply to foods containing oat hull fiber. Accordingly, this response should not be construed to be a statement that foods that contain oat hull fiber, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).
Based on the information provided by Grain Millers in GRN 000261, the supplement dated January 19, 2016, and the additional clarifying information received on April 7, 2016, and September 21, 2016, as well as other information available to FDA, the agency has no questions at this time regarding Grain Millers’ conclusion that oat hull fiber is GRAS under the intended conditions of use. The agency has not, however, made its own determination regarding the GRAS status of the subject use of oat hull fiber. As always, it is the continuing responsibility of Grain Millers to ensure that food ingredients that the firm markets are safe, and are otherwise in compliance with all applicable legal and regulatory requirements.
In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to the supplement to GRN 000261, as well as a copy of the information in this notice that conforms to the information in the GRAS exemption claim (proposed 21 CFR 170.36(c)(1)), is available for public review and copying at www.fda.gov/grasnoticeinventory.
Antonia Mattia, Ph.D.
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
cc: William K. Shaw Jr., Ph.D.
Stop Code 3782, Patriots Plaza III
1400 Independence Ave. SW
Washington, DC 20250-3700